Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-03-07 @ 11:47 PM
Study NCT ID:
NCT05456802
Status:
COMPLETED
Last Update Posted:
2024-09-24
First Post:
2022-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Acute Cardiovascular Disease on Microbiome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D000089802', 'term': 'Chronic Limb-Threatening Ischemia'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'stool and blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-22', 'studyFirstSubmitDate': '2022-06-30', 'studyFirstSubmitQcDate': '2022-07-09', 'lastUpdatePostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change of left ventricular global longitudinal strain (GLS) after presentation with ACS/CCS/CLI', 'timeFrame': 'Echocardiography will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.', 'description': 'Echocardiographical strain analysis will be performed at the below mentioned time points.'}, {'measure': 'Change of inflammatory profile (CRP, PCT, Interleukin panel) after presentation with ACS/CCS/CLI', 'timeFrame': 'Sampling will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.', 'description': 'Blood samples are collected at the below mentioned time points.'}, {'measure': 'Change of blood pressure after presentation with ACS/CCS/CLI', 'timeFrame': 'Blood pressure measurements will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.', 'description': 'Blood pressure will be measured at the below mentioned time points.'}, {'measure': 'Change of pulse wave velocity (PWV) after presentation with ACS/CCS/CLI', 'timeFrame': 'PWV measurements will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.', 'description': 'PWV will be measured at the below mentioned time points.'}, {'measure': 'Change in nitrite metabolism after presentation of ACS/CCS/CLI', 'timeFrame': 'Nitrite metabolism will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.', 'description': 'Nitrite metabolism will be assed by chemiluminescence detection (CLD).'}], 'primaryOutcomes': [{'measure': 'Change of enteral microbiome composition after presentation with ACS/CCS/CLI', 'timeFrame': 'Sampling will be performed within 24 hours of presentation to the clinic, at day 3, day 7, day 14 and at day 28 (+/- 2 days) after initial presentation.', 'description': 'Stool samples are collected at the below mentioned time points. DNA isolation will be performed with consecutive 16S-RNA analysis and cluster analysis.'}, {'measure': 'Change of oral microbiome composition after presentation with ACS/CCS/CLI', 'timeFrame': 'Sampling will be performed within 24 hours of presentation to the clinic, at day 3, day 7, day 14 and at day 28 (+/- 2 days) after initial presentation.', 'description': 'Oral samples are collected at the below mentioned time points. DNA isolation will be performed with consecutive 16S-RNA analysis and cluster analysis.'}], 'secondaryOutcomes': [{'measure': 'Change of TMAO serum levels after presentation with ACS/CCS/CLI', 'timeFrame': 'Sampling will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.', 'description': 'Blood samples are collected at the below mentioned time points. TMAO serum levels will be measured by ultra-high-performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS).'}, {'measure': 'Change of SCFA serum levels after presentation with ACS/CCS/CLI', 'timeFrame': 'Sampling will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.', 'description': 'Blood samples are collected at the below mentioned time points. SCFA serum levels will be measured by high-performance liquid chromatography (HPLC).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Microbial Colonization', 'Coronary Artery Disease', 'Myocardial Infarction', 'Acute Coronary Syndrome', 'Peripheral Arterial Disease', 'Critical Limb Ischemia']}, 'referencesModule': {'references': [{'pmid': '40804540', 'type': 'DERIVED', 'citation': 'Messiha D, Lange E, Tratnik A, M Westendorf A, Rinke M, Lenz S, Hendgen-Cotta UB, Buer J, Rassaf T, Rammos C. The influence of acute and chronic coronary syndrome on the gut microbiome and downstream microbiome-derived metabolites-Microbiome in acute myocardial infarction-MIAMI-Trial. Basic Res Cardiol. 2025 Oct;120(5):913-924. doi: 10.1007/s00395-025-01134-9. Epub 2025 Aug 13.'}]}, 'descriptionModule': {'briefSummary': 'Atherosclerotic diseases such as coronary artery disease (CAD) and peripheral arterial disease (PAD) are the leading cause of morbidity and mortality in the industrialized world.\n\nAn interaction between the development of atherosclerotic diseases and the oral and enteral microbiome composition has already been demonstrated in the past. The microbiome is a double-edged sword which can convey protective and detrimental cardiovascular effects. While it can promote the development of atherosclerosis through the production of atherogenic metabolites such as trimethylamine N-oxide (TMAO) it can also generate a protective effect through the production of metabolites such as short chain fatty acids (SCFA). Preliminary data suggest that atherosclerotic disease itself can induce a dysbiosis of the microbiome.\n\nAim of this study is to determine the differences in coronary artery disease and peripheral arterial disease on the oral-enteral microbiome axis and downstream microbiome-dependent metabolites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients older than 18 years presenting to the clinic with acute coronary syndrome (ACS), chronic coronary syndrome (CCS) or critical limb threatening ischemia (CLI) who can be included into the study within a 24 hours time frame after presentation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years\n* patient consent\n* CCS, ACS or CLI\n* angiographical confirmed peripheral or coronary artery disease\n\nExclusion Criteria:\n\n* pregnancy/lactation period\n* current antibiotic treatment or in the past 3 months\n* chronic inflammatory bowel disease\n* short bowel syndrome\n* artificial bowel outlet\n* persistent diarrhea or vomiting in the past 3 months\n* simultaneous participation in another interfering nutrition study\n* active chemo or radiation therapy'}, 'identificationModule': {'nctId': 'NCT05456802', 'acronym': 'MIAMI', 'briefTitle': 'Effect of Acute Cardiovascular Disease on Microbiome', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Essen'}, 'officialTitle': 'The Influence of a Symptomatic Coronary Artery and Peripheral Arterial Disease on the Oral-enteral Microbiome and Downstream Microbiome-dependent Metabolites', 'orgStudyIdInfo': {'id': 'MIAMI Trial'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute Coronary Syndrome (ACS)', 'description': 'Patients presenting to the clinic with acute coronary syndrome. This includes: ST-elevation myocardial infarction (STEMI), non-ST-elevation myocardial infarction (NSTEMI) and unstable angina pectoris (UAP) with confirmed diagnosis of coronary artery disease.', 'interventionNames': ['Other: Standard of care treatment']}, {'label': 'Chronic Coronary Syndrome (CCS)', 'description': 'Patients presenting to the clinic with chronic coronary syndrome and confirmed diagnosis of coronary artery disease.', 'interventionNames': ['Other: Standard of care treatment']}, {'label': 'Critical limb ischemia (CLI)', 'description': 'Patients presenting to the clinic with critical limb ischemia. This includes: Resting limb pain (Fontaine III), ulcerations (Fontaine IV) and Ankle brachial index (ABI) \\< 0,6 and confirmed diagnosis of peripheral artery disease.', 'interventionNames': ['Other: Standard of care treatment']}], 'interventions': [{'name': 'Standard of care treatment', 'type': 'OTHER', 'description': 'Standard of care treatment including percutaneous interventions was performed in all participants.', 'armGroupLabels': ['Acute Coronary Syndrome (ACS)', 'Chronic Coronary Syndrome (CCS)', 'Critical limb ischemia (CLI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45147', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'University of Essen, Clinic of Cardiology and Angiology', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}], 'overallOfficials': [{'name': 'Christos Rammos, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Clinic Essen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Essen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Dr. med.', 'investigatorFullName': 'Chistos Rammos', 'investigatorAffiliation': 'University Hospital, Essen'}}}}